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Sponsored by: |
Institute for Neurodegenerative Disorders |
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Information provided by: | Institute for Neurodegenerative Disorders |
ClinicalTrials.gov Identifier: | NCT00605059 |
The main objectives of this proposal are as follows:
To assess the dynamic uptake and washout of 123-I AV94, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged healthy controls and Alzheimer's (AD) subjects
To perform blood metabolite characterization of 123-I AV94 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I AV94 as a single photon computed tomography (SPECT) brain imaging agent
Evaluate the test/retest reproducibility of 123-I AV94 and SPECT in AD subjects and healthy controls
Condition |
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Alzheimer Disease |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | Evaluation of [123I] AV94 and SPECT as a Marker of Beta-Amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects |
Estimated Enrollment: | 20 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
General Design and Methods. The underlying goal of this study is to assess 123-I AV94 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 20 patients with Alzheimers disease (AD) and 10 healthy controls will be recruited to participate in this study. Healthy controls will be examined to ensure that there is no evidence of neurodegenerative changes including cognitive decline. Informed consent will be obtained for all. All subjects will undergo a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. Subjects will be asked to undergo a bolus injection of 123-I AV94. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I AV94 in plasma (both protein bound and free) over a period of up to 6 hours. Subjects may be asked to undergo a second imaging visit between 2 and 6 weeks following the initial imaging visit following similar procedures to the initial imaging visit to evaluate the reproducibility of the imaging measure using this procedure. The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I AV94. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the AD patients and controls will be compared. For those subjects undergoing repeat imaging visits, the data from the initial scan will be compared to the second scan to determine which offers the reproducibility of the imaging outcome measure.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Subject Recruitment. Subjects with mild to moderate AD will be recruited from community healthcare providers including internists, primary care physicians, neurologists, and AD subspecialty clinics and IND subject database. Healthy controls will be recruited from our healthy subject database and through advertising. Referred patients will be evaluated by a neurologist at IND. The neurologist will discuss the study procedures and evaluate the patient for eligibility. Written informed consent for the study will be obtained prior to performing any study-related procedures.
Alzheimer's Subject Selection. Subjects who have a clinical diagnosis of mild to moderate Alzheimer's disease will be recruited for this study. The following criteria will be met for inclusion of AD subjects in this study:
Alzheimer's subjects will be excluded from participation for the following reasons:
Concomitant therapy Patients may remain on a stable dose of anticholinesterase medication during the study. Use of donepezil (Aricept®), rivastigmine (Exelon®), galantamine (Razadyne®), tacrine (Cognex®), and memantine (Namenda®) are permitted during the study. Doses of these compounds must be stable for 2 months prior to the study. At each visit after the screening visit, the investigator will ask the patient whether any medications including OTC medications, were taken since the previous visit.
Use of antipsychotics for agitation and benzodiazepines for insomnia or anxiety is permitted. However, the use of these agents is not permitted within the 8 hours prior to administration of cognitive testing.
Healthy Control Subject Selection. Healthy control subjects who have no neurological disease will be recruited for this study. The following criteria will be met for inclusion of healthy control subjects in this study:
Healthy control subjects will be excluded from participation for the following reasons:
United States, Connecticut | |
Institute for Neurodegenerative Disorders | |
New Haven, Connecticut, United States, 06510 | |
Molecular NeuroImaging, LLC | |
New Haven, Connecticut, United States, 06510 |
Principal Investigator: | Danna L Jennings, MD | Institute for Neurodegenerative Disorders |
Responsible Party: | Institute for Neurodegenerative Disorders ( Danna Jennings, MD ) |
Study ID Numbers: | AV94 |
Study First Received: | January 16, 2008 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00605059 |
Health Authority: | United States: Institutional Review Board |
Alzheimer SPECT |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Healthy |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |